Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT05398120

Conditions

Clinical High-Risk

Psychological

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Skills Group

Study Details

Brief summary:

This study is intended to test the feasibility of an integrated cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT) skills group for adolescents and young adults at clinical high-risk (CHR) for psychosis. The current study applies a skills group drawing from evidence-based practices (e.g., cognitive behavioral therapy (CBT), dialectical behavioral therapy (DBT)) to those at CHR for psychosis. Up to 30 CHR individuals (starting with a minimum of 3 participants, N accounts for attrition as well), aged 13-18, already receiving clinical services within the HOPE team at University of Pittsburgh will be offered a weekly skills group. Data collected on feasibility and outcome measures will occur pre (within 1 month) -post (up to 4-5 months) and half-way (up to 2-3 months) through the intervention. Taken together, the aim of the proposed intervention is to provide novel insights regarding the utility of a newly developed intervention that integrates both CBT and DBT skills for those at CHR for psychosis.

Conditions

Clinical High-Risk

Psychological

Study ID

NCT05398120

Start date

Apr 26, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Participant Inclusion Criteria:

  • 13-18 years of age
  • Meet criteria for clinical high-risk syndrome (i.e., at clinical high risk for developing a psychotic disorder). CHR status is determined based off of scoring a 3 (moderate) - 5 (severe) on the Structured Interview for Psychosis-Risk Syndromes and/or having a first degree relative with psychotic disorder and/or the individual meets criteria for schizotypal personality disorder. Additionally individuals with a brief intermittent psychotic symptoms can be included as well (e.g., frankly psychotic symptoms that are very brief)
  • Individuals must be enrolled in the HOPE team at the University of Pittsburgh since this group is embedded within that service

Participation Exclusion Criteria:

  • Group member meeting criteria for a current/past psychotic disorder

Inclusion Criteria for Parents or Legal Guardians:

  • Must be the parent, legal guardian of a 13-18 year-old
  • For parents of CHR adolescents, their adolescent must meet criteria for a psychosis-risk syndrome

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Skills Group

There will be one condition which is the group and participants will complete feasibility and outcome measures at baseline, at midpoint, and at the end of the group.

Interventions

Skills Group

Adolescents and young adults with a CHR syndrome ages 13-18 will complete feasibility and outcome measures while participating in a weekly skills group for 6 months.

Primary outcome measure

  • Attrition [ Time Frame: Up to 5 months ]
  • Attendance [ Time Frame: Up to 5 months ]
  • Modified Quick Lecomte and Leclerc Scale [ Time Frame: Up to 5 months ]
  • Participation Scale [ Time Frame: Up to 5 months ]
  • Change from baseline in the participant group survey at up to 3 months [ Time Frame: Baseline vs. up to 3 months ]
  • Change from up to 3 months in the participant group survey at up to 5 months [ Time Frame: Up to 3 months vs up to 5 months ]
  • Change from baseline in the participant group survey at up to 5 months [ Time Frame: Baseline vs. up to 5 months ]
  • Change from baseline in Satisfaction with Therapy and Therapist Scale at up to 3 months [ Time Frame: Baseline vs. up to 3 months ]
  • Change from 3 months in Satisfaction with Therapy and Therapist Scale at up to 5 months [ Time Frame: Up to 3 months vs. up to 5 months. ]
  • Fidelity scores [ Time Frame: Up to 5 months ]

Central Contacts and Locations

Central contacts

Tina Gupta, PHD

412-246-5845guptat3@upmc.edu

Lauren Bylsma, PHD

412-624-8363bylsmalm@upmc.edu

Locations

Bellefield Towers

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Tina Gupta, MA

412-246-5845guptat3@upmc.edu

Principal Investigator:

Leslie Horton, PHD

More Information

Sponsor

University of Pittsburgh

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Group intervention
  • Dialectical behavioral therapy skills
  • Cognitive behavioral therapy skills
  • Psychosis-risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-02-10.